Liver CirrhosisNCT04406298
Safety and Efficacy of Small Frequent Paracentesis Using an Indwelling CAtheter Compared With Repeated Large Volume Paracentesis in Cirrhotic Patients With REfractory Ascites
A study testing small quantity paracentesis and Large Volume Paracentesis in people with Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
The aim of the study is to assess the efficacy of intermittent small quantity (upto 3L per day) paracentesis through an indwelling catheter for up to 5 days in comparison with large volume paracentesis on decreasing the need for repeated paracentesis by 50 % over next 3 months. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- small quantity paracentesis and Large Volume Paracentesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 4 Jul 2020to 20 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhotic patients 18-70 yrs with refractory severe ascites with stable renal function (S.creatinine < 2 mg/dl).
Who cannot join
- CTP >12, MELD>25
- Prior or current Spontaneous Bacterial Peritonitis (SBP)
- Recurrent or current overt hepatic encephalopathy
- Serum Creatinine >2
- HVOTO (Hepatic Venous Outflow Tract Obstruction)
- Hepatic or extrahepatic malignancy
Show all 9Show fewer
- Recent UGI bleed
- Sepsis
- Serum Sodium < 120
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Manasa Alla, MD, 01146300000, manasa1512@gmail.com
About this study
Official title: Safety and Efficacy of Small Frequent Paracentesis Using an Indwelling CAtheter Compared With Repeated Large Volume Paracentesis in Cirrhotic Patients With REfractory Ascites- A Randomized Controlled Trial (I-CARE)
The aim of the study is to assess the efficacy of intermittent small quantity (upto 3L per day) paracentesis through an indwelling catheter for up to 5 days in comparison with large volume paracentesis on decreasing the need for repeated paracentesis by 50 % over next 3 months. The project will be conducted at ILBS between April 2020 and March 2021. The concept of the study is to evaluate the efficacy of indwelling catheter in reducing the refilling rates of ascites by 50 % over 3 months in comparison to LVPs and also in reducing the incidence and risk of PPCD. All refractory ascites patients will be included as per inclusion and exclusion criteria, after taking informed consent from the patient or their relatives.
The expected outcomes are
Read more
Primary outcome: Proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis after a short duration (5day) intermittent small quantity (up to 3L/ day) paracentesis through an indwelling catheter in comparison to a single large volume paracentesis in the next 3 months.
Secondary outcome:
- Proportion of cirrhotic patients with refractory ascites developing P 2 . During a 30 D, 60 D and 90 D follow up, to assess between the groups
- Need for repeated paracentesis : Number assessed
- AKI : Improvement or worsening of renal functions
- Hepatic encephalopathy: Grading as per West Haven Classification
- Hyponatremia
- Diuretic tolerability : Dose and duration tolerated
- Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm
- Transplant free survival
- Risk of procedure related complications
- Changes in MELD or CTP between the groups ( Improvement vs worsening )
- Need for hospitalization between the groups
- Conditions
- Liver Cirrhosis
- Being tested
- small quantity paracentesis, Large Volume Paracentesis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
small quantity paracentesisProcedure or surgery
Intermittent small quantity paracentesis (upto 3L/day) for upto 5 days
Large Volume ParacentesisProcedure or surgery
Large Volume Paracentesis > 5litres
| Study group | Role | What they receive |
|---|---|---|
| Small Quantity Paracentesis | Experimental | Intermittent small quantity (upto 3L per day) paracentesis through an indwelling catheter for up to 5 days. Receives: Procedure: small quantity paracentesis |
| Large Volume Paracentesis | Active comparator | Large Volume Paracentesis > 5 litres Receives: Procedure: Large Volume Paracentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis in both groups
Measured: 3 Months
Secondary outcomes (36)
Number of participants which requires repeated paracentesis in both groups
Measured: 30 days
Number of participants which requires repeated paracentesis in both groups
Measured: 60 days
Number of participants which requires for repeated paracentesis in both groups
Measured: 90 days
Number of participants with AKI : Improvement or worsening of renal functions in both groups
Measured: 30 days
Number of participants with AKI : Improvement or worsening of renal functions in both groups
Measured: 60 days
Number of participants with AKI : Improvement or worsening of renal functions in both groups
Measured: 90 days
Number of participants with Hepatic Encephalopathy in both groups
Grading of Hepatic Encephalopathy will be as per West Haven Classification (Score 1 to 4) in both groups
Measured: 30 days
Number of participants with Hepatic Encephalopathy in both groups
Grading of Hepatic Encephalopathy will be as per West Haven Classification (Score 1 to 4) in both groups
Measured: 60 days
Number of participants with Hepatic Encephalopathy in both groups
Grading of Hepatic Encephalopathy will be as per West Haven Classification (Score 1 to 4) in both groups
Measured: 90 days
Number of participants with Hyponatremia in both groups
Measured: 30 days
Number of participants with Hyponatremia in both groups
Measured: 60 days
Number of participants with Hyponatremia in both groups
Measured: 90 days
Diuretic tolerability : Dose tolerated in both groups
Measured: 30 days
Diuretic tolerability : Dose tolerated in both groups
Measured: 60 days
Diuretic tolerability : Dose tolerated in both groups
Measured: 90 days
Diuretic tolerability : Duration tolerated in both groups
Measured: 30 days
Diuretic tolerability : Duration tolerated in both groups
Measured: 60 days
Diuretic tolerability : Duration tolerated in both groups
Measured: 90 days
Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups
Measured: 30 days
Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups
Measured: 60 days
Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups
Measured: 90 days
Transplant free survival in both groups
Measured: 30 days
Transplant free survival in both groups
Measured: 60 days
Transplant free survival in both groups
Measured: 90 days
Number of participants develop adverse events associated with procedure in both groups
Measured: 30 days
Number of participants develop adverse events associated with procedure in both groups
Measured: 60 days
Number of participants develop adverse events associated with procedure in both groups
Measured: 90 days
Change in Model for End Stage Liver Disease Score in both groups
MELD Score ranges from 6 to 40
Measured: 30 days
Change in Model for End Stage Liver Disease Score in both groups
MELD Score ranges from 6 to 40
Measured: 60 days
Change in Model for End Stage Liver Disease Score in both groups
MELD Score ranges from 6 to 40
Measured: 90 days
Change in CTP (Child-Turcotte-Pugh) Score in both groups
Child class A: < 7 points. Child class B: 7-9 points. Child class C: ≥10 points
Measured: 30 days
Change in CTP (Child-Turcotte-Pugh) Score in both groups
Child class A: < 7 points. Child class B: 7-9 points. Child class C: ≥10 points
Measured: 60 days
Change in CTP (Child-Turcotte-Pugh) Score in both groups
Child class A: < 7 points. Child class B: 7-9 points. Child class C: ≥10 points
Measured: 90 days
Number of patients required hospitalization between the groups
Measured: 30 days
Number of patients required hospitalization between the groups
Measured: 60 days
Number of patients required hospitalization between the groups
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start4 Jul 2020
- Primary completion20 May 2021 (estimated)
- Study completion20 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406298
- Sponsor's protocol ID
- ILBS-Cirrhosis-29
- Status last verified
- May 2020
- First submitted
- 15 May 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Small Frequent Paracentesis Using an Indwelling CAtheter Compared With Repeated Large Volume Paracentesis in Cirrhotic Patients With REfractory Ascites- A Randomized Controlled Trial (I-CARE)
- ClinicalTrials.gov ID
- NCT04406298
- Acronym / sponsor ID
- ILBS-Cirrhosis-29
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 4 Jul 2020 (actual)
- Primary completion
- 20 May 2021 (estimated)
- Study completion
- 20 May 2021 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to assess the efficacy of intermittent small quantity (upto 3L per day) paracentesis through an indwelling catheter for up to 5 days in comparison with large volume paracentesis on decreasing the need for repeated paracentesis by 50 % over next 3 months. The project will be conducted at ILBS between April 2020 and March 2021. The concept of the study is to evaluate the efficacy of indwelling catheter in reducing the refilling rates of ascites by 50 % over 3 months in comparison to LVPs and also in reducing the incidence and risk of PPCD. All refractory ascites patients will be included as per inclusion and exclusion criteria, after taking informed consent from the patient or their relatives.
The expected outcomes are
Primary outcome: Proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis after a short duration (5day) intermittent small quantity (up to 3L/ day) paracentesis through an indwelling catheter in comparison to a single large volume paracentesis in the next 3 months.
Secondary outcome:
- Proportion of cirrhotic patients with refractory ascites developing P 2 . During a 30 D, 60 D and 90 D follow up, to assess between the groups
- Need for repeated paracentesis : Number assessed
- AKI : Improvement or worsening of renal functions
- Hepatic encephalopathy: Grading as per West Haven Classification
- Hyponatremia
- Diuretic tolerability : Dose and duration tolerated
- Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm
- Transplant free survival
- Risk of procedure related complications
- Changes in MELD or CTP between the groups ( Improvement vs worsening )
- Need for hospitalization between the groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small Quantity Paracentesis | Experimental | Procedure: small quantity paracentesisIntermittent small quantity (upto 3L per day) paracentesis through an indwelling catheter for up to 5 days. |
| Large Volume Paracentesis | Active comparator | Procedure: Large Volume ParacentesisLarge Volume Paracentesis > 5 litres |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cirrhotic patients 18-70 yrs with refractory severe ascites with stable renal function (S.creatinine < 2 mg/dl).
Key exclusion criteria (9 listed)
- CTP >12, MELD>25
- Prior or current Spontaneous Bacterial Peritonitis (SBP)
- Recurrent or current overt hepatic encephalopathy
- Serum Creatinine >2
- HVOTO (Hepatic Venous Outflow Tract Obstruction)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| small quantity paracentesisIntermittent small quantity paracentesis (upto 3L/day) for upto 5 days | Procedure or surgery | Small Quantity Paracentesis |
| Large Volume ParacentesisLarge Volume Paracentesis > 5litres | Procedure or surgery | Large Volume Paracentesis |
Primary outcome
Proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis in both groups
Time frame: 3 Months
36 secondary outcomes
Number of participants which requires repeated paracentesis in both groups
Time frame: 30 days
Number of participants which requires repeated paracentesis in both groups
Time frame: 60 days
Number of participants which requires for repeated paracentesis in both groups
Time frame: 90 days
Number of participants with AKI : Improvement or worsening of renal functions in both groups
Time frame: 30 days
Number of participants with AKI : Improvement or worsening of renal functions in both groups
Time frame: 60 days
Number of participants with AKI : Improvement or worsening of renal functions in both groups
Time frame: 90 days
Number of participants with Hepatic Encephalopathy in both groups
Time frame: 30 days
Number of participants with Hepatic Encephalopathy in both groups
Time frame: 60 days
Number of participants with Hepatic Encephalopathy in both groups
Time frame: 90 days
Number of participants with Hyponatremia in both groups
Time frame: 30 days
Number of participants with Hyponatremia in both groups
Time frame: 60 days
Number of participants with Hyponatremia in both groups
Time frame: 90 days
Diuretic tolerability : Dose tolerated in both groups
Time frame: 30 days
Diuretic tolerability : Dose tolerated in both groups
Time frame: 60 days
Diuretic tolerability : Dose tolerated in both groups
Time frame: 90 days
Diuretic tolerability : Duration tolerated in both groups
Time frame: 30 days
Diuretic tolerability : Duration tolerated in both groups
Time frame: 60 days
Diuretic tolerability : Duration tolerated in both groups
Time frame: 90 days
Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups
Time frame: 30 days
Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups
Time frame: 60 days
Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups
Time frame: 90 days
Transplant free survival in both groups
Time frame: 30 days
Transplant free survival in both groups
Time frame: 60 days
Transplant free survival in both groups
Time frame: 90 days
Number of participants develop adverse events associated with procedure in both groups
Time frame: 30 days
Number of participants develop adverse events associated with procedure in both groups
Time frame: 60 days
Number of participants develop adverse events associated with procedure in both groups
Time frame: 90 days
Change in Model for End Stage Liver Disease Score in both groups
Time frame: 30 days
Change in Model for End Stage Liver Disease Score in both groups
Time frame: 60 days
Change in Model for End Stage Liver Disease Score in both groups
Time frame: 90 days
Change in CTP (Child-Turcotte-Pugh) Score in both groups
Time frame: 30 days
Change in CTP (Child-Turcotte-Pugh) Score in both groups
Time frame: 60 days
Change in CTP (Child-Turcotte-Pugh) Score in both groups
Time frame: 90 days
Number of patients required hospitalization between the groups
Time frame: 30 days
Number of patients required hospitalization between the groups
Time frame: 60 days
Number of patients required hospitalization between the groups
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing small quantity paracentesis and Large Volume Paracentesis in people with Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Manasa Alla, MD (01146300000, manasa1512@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis in both groups (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.